Automated Structured Education Intervention Based on an App and Artificial Intelligence in Chinese Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- changes in serum hemoglobin A1c level
研究概览
简要总结
In recent years, more and more attention has been paid to diabetes self-management. Glycemic control and self-management skills of patients with type 1 diabetes (T1DM) in China are poor. Artificial intelligence (AI) and the Internet offer a new way to improve the self-management skills of patients with chronic diseases. Few studies have combined AI technology with structured education intervention of type 1 diabetes. This study is innovative in that it compares the effectiveness of smartphone app between usual care, as well as automatic and individualized app education and standardized app education to explore whether the individualized treatment advocated by the latest guideline will bring any additional benefit to T1DM patients. The ultimate goal is to provide an effective and convenient approach for glycemic control of type 1 diabetes and reduce related disease burden in China.
详细描述
This is a single-blinded, 1:1 paralleled group cluster randomized controlled trial (RCT). The intervention will last for 24 weeks. The laboratory staff who test the HbA1c level, the outcome assessor who collects the blood glucose data, and the statisticians will be blinded to the treatment allocation.
Sample size estimation: We propose to enroll 138 patients with type 1 diabetes (T1DM) by considering withdrawals, 69 in the smartphone app groups and 69 in the routine care group. Sample size estimation is based on hypothesized changes in the primary outcome HbA1c.
In order to ensure high quality data, two staff are responsible for the input of original data into the database to check and confirm the accuracy. When the data entered by two staff independently, the auxiliary staff decides which data to use.
Data analysis will be conducted under the intention-to-treat principle by including all the randomized patients in the data analysis. Missing data will be filled in with multiple imputation method. Any substantial difference in baseline characteristics will be adjusted with mixed-model regression analysis. Sensitivity analysis will be conducted by using per-protocol data by excluding those patients who drop out of the RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report
- •Insulin dependence from disease onset
- •Aged 18-50 years
- •With a disease duration over 6 months
- •With a HbA1c level over 7%
- •Treated T1DM with multiple daily injections or insulin pump
- •Individuals who own smartphone and are capable of using wechat or apps
排除标准
- •Age below 18 years or above 50 years
- •Being pregnant
- •With mental disorders
- •Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial
- •Already using a smartphone app for managing diabetes
- •Having chronic complications including diabetic retinopathy, diabetic nephropathy or diabetic foot, diabetic neuropathy
结局指标
主要结局
changes in serum hemoglobin A1c level
时间窗: from baseline to week 12, 24
A1c reflects the average blood glucose level in the past 2-3 months.
次要结局
- Diastolic blood pressure(from baseline to week 12, 24)
- changes in Time in range (TIR)(from baseline to week 12, 24)
- Chinese version of Diabetes Quality of Life scale(from baseline to week 12, 24)
- Diabetes Empowerment Scale-Short Form(from baseline to week 12, 24)
- State-Trait Anxiety Inventory (STAI)(from baseline to week 12, 24)
- Total cholesterol(from baseline to week 12, 24)
- Low-density lipoprotein (LDL) cholesterol(from baseline to week 12, 24)
- Height in meters(from baseline to week 12, 24)
- Patients engagement with the app(automatically collected by the app from baseline to week 24)
- Fasting blood glucose(from baseline to week 12, 24)
- Adverse events(every 4 weeks from baseline to week 24)
- Diabetes Self-Management Scale(from baseline to week 12, 24)
- Chinese version of Diabetes Self-Care Activities(from baseline to week 12, 24)
- Beck's Depression Inventory (BDI)(from baseline to week 12, 24)
- High-density lipoprotein (HDL) cholesterol(from baseline to week 12, 24)
- Triglycerides(from baseline to week 12, 24)
- Systolic blood pressure(from baseline to week 12, 24)
- Weight in kilograms(from baseline to week 12, 24)
研究者
Xia Li
Professor, Department of Endocrinology, Institute of of Metabolism and Endocrinology, Nationa Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University
Second Xiangya Hospital of Central South University